Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study.

Recruiting

Conditions: Spina Bifida

Registration Number: NL-OMON27522

Lead Sponsor: Erasmus MC, Dept. Urology

Brief Summary: ot applicable.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

The study group exists of newborns with MMC who are treated with the standard treatment (CIC and anticholinergics). The minimal age at inclusion is 3 months. This is because of the minimal diameter of the urethra which is necessary for cystoscopy.

Exclusion Criteria

- Patients with swallowing or breathing problems for which medical treatment is or was necessary.

- Muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis or the Syndrome of Eaton-Lambert.

For the historical group the database of (parents of) patients who object against the use of their medical records for research purposes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
End filling pressure of the bladder(determined by means of urodynamic testing) after 5 years of follow-up.

Secondary Outcome Measures

Name	Time	Method
- Clinical parameters:<br /><br>o Number of urinary tract infections<br /><br>o Frequency of intermittent catheterisation<br /><br>o Bladder volumes (with intermittent catheterisation)<br /><br><br /><br>- Urodynamic parameters:<br /><br>o Bladder capacity<br /><br>o Bladder overactivities<br /><br>o Compliance of the bladder<br /><br><br /><br>- Number and nature of operative interventions to the urinary tract.<br />